Emotional Experiences in Fathers of NICU Infants

Stress Clinical Trial

Official title:

Emotional Experiences in Fathers of NICU Babies: A Comparison of Fathers in Medical and Surgical NICUs.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306605
• Other study ID #: 26047
• Status: Completed
• Phase: N/A
• First received: March 22, 2006
• Last updated: June 19, 2017
• Start date: March 2006
• Est. completion date: November 2008

Study information

• Verified date: June 2017
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to evaluate the emotional experiences of fathers who have preterm infants who are hospitalized in a (neonatal intensive care unit)NICU setting. In addition, we will compare the emotional responses experienced by father of surgical NICU babies and fathers of medical NICU babies.

Our primary hypothesis is that paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.

Secondary hypotheses include: 1) Stress levels for fathers of hospitalized infants will decrease over time; 2) Depressive symptomatology modulates perceived stress in fathers of NICU infants.

Description:

It is well known that birth and hospitalization of a preterm infant is stressful for parents. Numerous studies have evaluated emotional factors such as maternal stress, parental role alteration, and maternal depression. Researchers have also investigated both maternal and paternal emotional responses in relation to their infant being hospitalized in the NICU. Studies examining paternal response alone have received less research attention. To date, no studies have compared the emotional response of fathers of medical NICU babies and fathers of surgical NICU babies.

The purpose of this study is to evaluate and compare perceived paternal stress and depressive symptomatology in fathers of preterm medical and surgical infants. Fathers who agree to participate will be given a questionnaire that is comprised of two self-report tools. Together these tools should take approximately 15-20 minutes to complete. Fathers who participate will be asked to complete these tools at three different times throughout their infants' stay in the NICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• consenting fathers who are English speaking

• fathers with preterm infants < 30 weeks gestation and who are likely to survive

• Infants who lack congenital or genetic abnormalities likely to be associated with significant neurodevelopmental handicaps.

Exclusion Criteria:

• There are no specific exclusion criteria.

Related Conditions & MeSH terms

• Depressive Symptomatology
• Stress

Intervention

Behavioral:
• Questionnaire
Participants will be asked to complete a questionnaire 3 times throughout the first 5 weeks after their infant's birth / hospitalization

Locations

Country	Name	City	State
United States	Christiana Hospital (Christiana Care Health Systems)	Newark	Delaware
United States	A.I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	Alfred I. duPont Hospital for Children

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miles MS, Brunssen SH. Psychometric properties of the parental stressor scale: infant hospitalization. Adv Neonatal Care. 2003 Aug;3(4):189-96. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived paternal stress levels will be lower for those fathers of infants who are hospitalized in a medical NICU compared with fathers of infants who are hospitalized in a surgical NICU.		First 5 weeks of infant's life and / or hospitalization
Secondary	Stress levels for fathers of hospitalized infants will decrease over time.		Within the first 5 weeks of their infant's birth / hospitalization
Secondary	Depressive symptomatology modulates perceived stress in fathers of infants in NICUs.		First 5 weeks after their infant's birth / hospitalization